Veterinary Biologics Guideline 3.33
Guideline for Commercial Importers of Veterinary Biologics in Canada

Table of Contents

I. Introduction

Veterinary biologics include vaccines, antibody products, and test kits used for the prevention, treatment, or diagnosis of infectious diseases of animals. These products are regulated in Canada by the Canadian Centre for Veterinary Biologics (CCVB) under the authority of the Health of Animals Act and Regulations. Veterinary biologics are regulated to protect the health and well-being of Canadian animals, the general public, and the environment by ensuring that veterinary biologic products used in animals are safe, pure, potent, and efficacious. The CCVB is responsible for licensing veterinary biologics and for regulating their importation and use. Once a veterinary biologic manufactured outside Canada is licensed by the CCVB, a commercial import permit is issued to the Canadian importer, designated by the manufacturer, for distribution and sale of the product in Canada. Commercial import permits are issued only for the importation of licensed veterinary biologics. Please consult the CCVB website for a list of Veterinary Biologics Licensed in Canada.

This guideline is primarily intended for new importers; however, the standards also apply to existing facilities.

II. Legal Authority

Health of Animals Regulations, Part XI

121.(1) No person shall import a veterinary biologic into Canada unless he does so under and in accordance with a permit issued by the Minister.

(1.1) Where a permit referred to in subsection (1) has been issued, the veterinary biologic shall be shipped directly to Canada from the manufacturer's premises or from such other premises, in which veterinary biologics may be lawfully manufactured under the applicable foreign laws, that were designated in the application for the permit.

122.(4) Every person to whom a permit is issued to import a veterinary biologic shall

  1. keep and make available for inspection by a veterinary inspector a record in a form approved by the Minister with respect to the importation, sale and distribution of the veterinary biologic and retain that record for at least two years following the expiration date of the veterinary biologic to which the record relates; and
  2. furnish the Minister with such samples of the veterinary biologic as the Minister may require from time to time.

130.1 Every veterinary biologic imported, sold, advertised or offered for sale in Canada shall be stored at a temperature between 2°C and 7°C unless otherwise stated in the product outline or the labelling.

131. Where the Minister is satisfied from tests of a veterinary biologic, or otherwise, that a veterinary biologic is unsafe to use, is likely to cause communicable disease in animals or is contaminated or ineffective, he may, by order, prohibit the importation, manufacture, sale or distribution of the veterinary biologic.

132.(1) No person shall import, sell, advertise, or offer for sale a veterinary biologic unless it is packed and labelled in accordance with these Regulations.

134.1 No person shall sell or offer for sale a veterinary biologic after its expiration date.

134.2(1) Except as provided in subsection (2), no person shall sell or offer for sale a rabies vaccine to anyone other than a veterinarian of the Department of Agriculture of Canada or a veterinarian who holds a valid licence to practice veterinary medicine issued by the veterinary licensing body of a province.

135.(1) No person shall, in any advertisement for the sale of a veterinary biologic, make any claim with respect to the purity, safety, potency and efficacy of the veterinary biologic that is not supported by the product outline for such veterinary biologic.

135.1 Every holder of a licence or permit issued under this Part shall report to the Minister, in writing, any information concerning or any evidence of, a significant deficiency in safety, potency or efficacy of a veterinary biologic within 15 days from the date on which such information or evidence is known to him or is generally known to the industry, whichever is earlier.

III. Requirement for an Import Permit

A significant number of veterinary vaccines, antibody products, and diagnostic kits used in Canada are imported from other countries, including the United States, Australia, New Zealand, and some European countries. The importation of any veterinary biologic into Canada requires a valid import permit issued by the CCVB. There is no exemption from the import permit requirement for small shipments, personal use, or for emergency or research use. Commercial import permits are issued by the CCVB for products that are licensed for use in Canada, only to the importer(s) designated by the manufacturer. The product(s) must be shipped directly from the manufacturer from the address(es) listed on the import permit to the importer or the quarantine/destination, or to the other destination identified on the import permit. Importation of veterinary biologics from wholesale dealers, retail outlets, or Internet pharmacies outside Canada is not permitted. Import permits for commercial importation of veterinary biologics in Canada are generally valid for one year, and must be renewed annually before, or on, April 30.

The designated Canadian commercial importer is frequently a subsidiary of the manufacturer located outside Canada and is delegated responsibility for providing distribution, marketing, and technical support to customers in Canada. The designated importer also acts as the contact with the CCVB on behalf of the manufacturer to report suspected adverse events, and to conduct stop sales, product recall, and market withdrawal, if necessary. A foreign manufacturer may designate more than one importer in Canada and, in this case, each importer is required to obtain a separate import permit. A Canadian importer may obtain import permits for the importation of veterinary biologics from more than one foreign manufacturer. The importers are subject to inspection by the CFIA and are responsible for complying with the regulatory requirements that relate to veterinary biologics, set out in the Health of Animals Act and Regulations and in the conditions stipulated on the import permit(s).

IV. Procedure for Applying for an Import Permit

The following is a list of key documents required to support an application for becoming a commercial importer of veterinary biologics in Canada. Depending on circumstances, additional documents may be required.

The following documents must be submitted to CCVB, Ottawa.

1. Covering letter introducing the importing company, its intentions for importing veterinary biologics, and identifying the person who will serve as the regulatory liaison.

2. Form CFIA/ACIA 4720 – Application for Services – and applicable fees.   

3. Form CFIA/ACIA 1493 – Application for Permit to Import Veterinary Biologics into Canada – signed by the importer’s designated contact person.  

4. Form CFIA/ACIA 1503 – Veterinary Biologic Information – signed by the regulatory affairs person of the foreign manufacturer.

In addition, the following documents must be submitted directly to the attention of the CFIA Area Veterinary Biologics Operations (VBO) Veterinarian:

5. Organizational Chart – Identify the key personnel involved in the management of veterinary biologics, along with their reporting relationship and main duties. Depending on the size of the company, this must include the company's manager and/or director, the regulatory affairs officer, the main CCVB/VBO contact, and the person(s) responsible for the following: warehouse, main equipment (e.g. coolers, refrigerators, generator, autoclave, liquid nitrogen tanks), quality assurance (e.g. validation or verification of certified thermometers), returned products, reporting suspected adverse events/reactions, stop sales, and product recalls to CCVB/VBO. The backup personnel for these key responsibilities should also be identified.

6. Plot Plan – Identify the physical location of each building and structure on the premises, the surrounding area, and adjacent buildings and structures. The plot plan must include a list identifying each building and structure, the location of property boundaries and the identification of directly adjacent properties (business type and name), access routes, fire routes, parking area(s), loading dock, and directional indication.

7. Blueprint – Identify, on the official blueprint or "site plan," all rooms in which veterinary biologics and related materials are imported, received, packaged, stored, distributed, and/or disposed. It must also show the identification and location of any equipment attached to the building (e.g. generator, liquid nitrogen tanks) that are used for veterinary biologics. The designated quarantine area(s) must be identified.

8. Blueprint/Site Plan Legend – Identify each room by a code (letter/number) on the blueprint/site plan, and describe its function in the blueprint legend. The location of each large piece of equipment, essential to veterinary biologics (e.g. walk-in cooler, refrigerator, freezer, autoclave), must also be identified by a code (number/letter) on the blueprint and a room-wise list provided in the blueprint legend.

Documents requested in items 5 to 8 must include the following details: the name and address of the company, the name and signature of the person who is responsible for these documents, and the date that these documents were prepared.

9. Standard Operating Procedures (SOPs) – Importers must have written, clear, detailed procedures or work instructions for each of the following activities:

  1. Monitoring the temperature of the veterinary biologic during shipping and storage:

    Importers must have a written protocol, describing the temperature-monitoring methods, including the frequency of monitoring, the type of records, the acceptable limits, the notification procedure or policy, and the corrective action taken in case of non-conformity. Facilities must have at least a certified minimum and maximum thermometer for recording temperature in degree Celsius (°C). The minimum and maximum temperature of the storage area must be recorded on a daily basis, and records must be maintained for review during the inspection of the facility.

  2. Identifying, monitoring, maintaining, and repairing critical equipment (e.g. walk-in coolers, freezers, liquid nitrogen tanks, backup generator), including an emergency backup plan
  3. Sanitizing the facility and equipment
  4. Ensuring that the imported veterinary biologics have CCVB approved labels before releasing the product for sale in Canada
  5. Receiving, secure storage, shipping, inventory control, and traceability of the product
  6. Conducting vermin control
  7. Disposing biomedical waste, returned product, and outdated inventory
  8. Stopping sale and product recall

  9. Handling customer complaints and reporting suspected adverse events/reactions

    Identify the specific responsibility of the manufacturer and the importer in investigating and reporting suspected adverse events and/or reactions.

  10. Checking that an internal self-inspection procedure is conducted by company representatives
  11. Developing SOPs for other activities, as required

Other procedures might be included as required. Each SOP must describe a step-by-step description of each activity, as well as approved recording and reporting formats. A copy of all SOPs must be submitted to the Area VBO Veterinarian for review.

10. A copy of the written agreement between the manufacturer and importer – clearly outlining the responsibilities of each and the conditions under which they will handle investigation and reporting of suspected adverse events and/or reactions, product recall, and stop sale.

11. A letter from the manufacturer that indicates

  1. a copy of the CCVB approved stamped labels of the veterinary biologic to be imported will be provided to the importer. Commercial importers are required to have copies of the current CCVB approved stamped labels for all products listed on the import permit. Importers must verify that the imported veterinary biologic has a CCVB approved stamped label before releasing the product for sale in Canada.
  2. a copy of APHIS Form 2008: VETERINARY BIOLOGICS PRODUCTION AND TEST REPORT or Manufacturer’s Serial Release Test Report (MSRTR) will be provided to the importer for each serial of veterinary biologic imported into Canada. Commercial importers are required to keep copies of APHIS Form 2008 or MSRTR for each serial of imported veterinary biologic on file at their facility.

Once documents # 5 to 11 are received, reviewed, and found satisfactory by the Area VBO Veterinarian, he/she notifies the CCVB, Ottawa to further process the commercial import permit application. Additional documents may be required to complete the application process. The Area VBO Veterinarian will also contact the designated Canadian importer to arrange for an inspection of the new facility. For additional information, please consult Veterinary Biologics Guideline 3.24E - Guidelines for Inspection of Veterinary Biologics Importers.

These inspections are generally conducted once every three years and are cost recovered. Depending upon the inspection findings, major changes in the company's structure, or other circumstances, additional on-site inspections may be required within the three-year period. In accordance with the Canadian Food Inspection Agency Fees Notice, Part 11, importers are required to pay an inspection fee of $380 (plus applicable taxes), as well as the related costs of the inspector’s travel, accommodation, meals, and incidentals, according to Federal Treasury Board guidelines.

V. Related Guidelines and References

Please consult the CCVB website for more detail, as well as to review all guidelines, forms, including the Canada Border Services Agency Memorandum D1-4-1 for invoice requirements pertaining to commercial goods imported into Canada.

VI. Additional Information

Further questions from manufacturers and importers, or requests for clarification regarding requirements for importing veterinary biologics for non-commercial purposes or unlicensed veterinary biologics, may be directed to an Area VBO Veterinarian or the CCVB.